Actively Recruiting

Phase Not Applicable
Age: 18Years - 30Years
All Genders
Healthy Volunteers
ID06878781

Standardized Meals With Different Macronutrient Ratios on the Postprandial Metabolome and Metabolic Flexibility

Led by Instituto Nacional de Medicina Genomica · Updated on 2025-03-17

300

Participants Needed

1

Research Sites

46 weeks

Total Duration

On this page

Sponsors

I

Instituto Nacional de Medicina Genomica

Lead Sponsor

U

Universidad Nacional Autonoma de Mexico

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating metabolic flexibility, the body's ability to switch between energy sources, which is important for health and linked to risks like obesity, metabolic syndrome, insulin resistance, and type 2 diabetes. This study focuses on how metabolic flexibility and the body's metabolome change after consuming standardized meals with different mixes of carbohydrates, fats, and proteins. The goal is to understand how the body responds to these meals during the postprandial state, the period after eating. Participants receive three different standardized meal challenges in a randomized order: a high carbohydrate meal, a high fat meal, and a high protein meal. Each meal must be consumed within 15 minutes, followed by a 5-minute rest and then 30 minutes of indirect calorimetry to measure metabolism. Capillary blood samples are taken before and at multiple time points after eating to analyze glucose, lipids, cholesterol, insulin, amino acids, and acyl-carnitines. The study lasts one month, with weekly visits where participants complete questionnaires about activity and diet and provide blood samples and metabolic measurements. Researchers assess metabolic flexibility using respiratory quotient and substrate oxidation, and monitor postprandial glucose, triglycerides, amino acids, and acyl-carnitines. Participants follow fasting and dietary instructions before each test. This comprehensive approach aims to provide insights into metabolic health based on responses to different meal compositions.

CONDITIONS

Brief Title

Postprandial Metabolome and Metabolic Flexibility

Who Can Participate

Age: 18Years - 30Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 18 and 30 years old
  • Have no active drug addictions such as smoking, alcoholism, or drug use
  • Female participants must have regular menstrual cycles
  • Provide written consent to join the study
Not Eligible

You will not qualify if you...

  • Have diseases requiring medication or special treatment, including diabetes, high blood pressure, dyslipidemia, polycystic ovary syndrome, autoimmune, thyroid, kidney, neurological diseases, or cancer
  • Are pregnant or breastfeeding
  • Have problems with chewing, salivation, or swallowing

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 weeks

Participants receive three different standardized meal challenges in a randomized order. Each challenge involves fasting overnight, followed by fasting indirect calorimetry, consumption of the test meal within 15 minutes, postprandial indirect calorimetry for 30 minutes, and multiple capillary blood samples collected over 2 hours to assess metabolic and hormonal responses.

Weekly visits for 3 weeks

Follow-up

Duration - 1 month

Participants are monitored weekly for one month with questionnaires assessing daily activity, health status, dietary intake, and anthropometric measurements.

Weekly visits for up to 4 weeks

Trial Site Locations

Total: 1 location

1

Berenice Palacios-Gonzalez

Mexico City, Mexico, 14610

Actively Recruiting

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Research Team

B

Berenice Palacios-Gonzalez, PhD

N

Noemi Meraz-Cruz, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

3

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Published Research Related To This Trial

Acute Effects of Three Different Meal Patterns on Postprandial Metabolism in Older Individuals with a Risk Phenotype for Cardiometabolic Diseases: A Randomized Controlled Crossover Trial.

Yannik B Schönknecht, Silke Crommen, Birgit Stoffel-Wagner...

https://pubmed.ncbi.nlm.nih.gov/32223057

Metabolic flexibility during normal pregnancy allows appropriate adaptation during gestation independently of BMI.

Jaime A Delgadillo-Velázquez, Rafael Nambo-Venegas, Nayelli Patiño...

https://pubmed.ncbi.nlm.nih.gov/34330475

Investigating the Postprandial Metabolome after Challenge Tests to Assess Metabolic Flexibility and Dysregulations Associated with Cardiometabolic Diseases.

Gaïa Lépine, Marie Tremblay-Franco, Sabrine Bouder...

https://pubmed.ncbi.nlm.nih.gov/35276829